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U.S. Department of Health and Human Services

Class 1 Device Recall Bassinet

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  Class 1 Device Recall Bassinet see related information
Date Initiated by Firm October 14, 2011
Date Posted February 01, 2012
Recall Status1 Terminated 3 on November 27, 2012
Recall Number Z-0832-2012
Recall Event ID 60615
Product Classification Bassinet, hospital - Product Code NZG
Product Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04

The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
Code Information Model BSNT/01 and BSNT/02 manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present.
Recalling Firm/
Manufacturer		 Nemschoff Chairs, Inc.
909 N 8th St
Sheboygan WI 53081-4056
For Additional Information Contact C. Kent Gawart
920-459-1230
Manufacturer Reason
for Recall		 To correct issues with casters, door hinges, drawer slides, and the bassinet surround. Also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
FDA Determined
Cause 2		 Device Design
Action The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.
Quantity in Commerce 1214 units.
Distribution Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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